N/A
Completed N=36
Virtual Reality Guided Imagery for Chronic Pain
Complex Regional Pain Syndromes · Back Pain
Source: ClinicalTrials.gov NCT04849897 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log — 60 Participants
Summary
To assess treatment with an at-home Virtual Reality Guided Imagery (VR-GI) intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log |
60 | — |
| PRIMARY Number of Enrolled Participants Who do Not Complete the Study as Documented in Log |
3; 1 | — |
| PRIMARY Number of Practice Sessions Completed by Participants as Documented in Spread Sheet |
10.8; 11.4 | — |
| PRIMARY Pain Assessed by Pain Numeric Rating Scale |
0.381; 0.091; 4; 3.92; 3.71; 3.64 | — |
| PRIMARY Opioid Medication Usage Assessed by Frequency of Use Log |
0; 1 | — |
| PRIMARY Non-opioid Pain Medication Usage Assessed by Frequency of Use Log |
6; 3 | — |
| SECONDARY Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) |
-1.2; -.06; 1.83; 1.58; 0.9; 1.2 | — |
| SECONDARY Depression Assessed by the Patient Health Questionnaire PHQ-2 |
-1.10; 0; 2; 1.33; 0.86; 1.3 | — |
| SECONDARY Short Form Health Survey (SF12v12) |
7.3; -1.85; 27.0; 29.1; 27.9; 27.7 | — |
| SECONDARY Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) |
-3.44; -4.83; 24.6; 25.8; 20.8; 21 | — |
| SECONDARY Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion |
— | — |
| SECONDARY Daily Pain Numerical Rating Scale |
-0.906; -.757; 5.75; 5.49; 4.82; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Must be a patient at the University of Southern California Pain Center
- - English Fluency
- Diagnosis of chronic back pain or complex regional pain syndrome
- Average pain intensity of 5 on a 0 to 10 scale for more than 3 month
- Access to a device with video and audio capability and sufficient WiFI to participate in on-line sessions
Exclusion Criteria
- History of significant motion sickness
- Active nausea/vomiting
- Epilepsy
- Significant movement problems
- Significant vision or hearing impairment
Data sourced from ClinicalTrials.gov (NCT04849897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.